Starting to get Involved

We are manufacturer of Medical device Class IIb and facing one situation related to the exported machines.

Please suggest if our dealer does not disclose the customer details to us & they don’t do the preventive maintenance of those machines properly. So in case of any adverse incident happens due to negligence in preventive maintenance then we as a company will be held responsible. There is any document have that makes such disclosure mandatory from regulatory stand point OR in case the dealer does not want to disclose the details of end customer then can we take undertaking from the dealer to take ownership in case of any adverse incident.

I don't see how a manufacturer can be held responsible for the negligent activities of a distributor

the manufacturer is responsible for providing adequate instructions (which may include contacting them to carry out the preventative maintenance), for feeding any PMS back into their risk assessment and for reporting incidents. Manufacturers should not be held responsible for the each and every problem caused by the supply chain, end user or patient if they have put adequate measures in place to reduce/mitigate the risk

I would suggest building a requirement for these type of event into the contract with the distributor or dealer. That way you clearly give them the responsibility and show you have done everything as manufacturer that you can do.